Irma System Wireless Notifications; Wireless Qos & Range Requirements; Wireless Security Recommendations; Ncc E-Labelling Access - LifeHealth IRMA Manual Del Usuario

Document Identifier
ANSI C63.27:2017
G.12 IRMA System Wireless Notifications
The following notifications regarding the wireless capabilities of the IRMA System have been added to Appendix B of the
IRMA System user manual:
Wireless QoS & Range Requirements
QoS: None. Best‐effort delivery service is sufficient.
Range: 20 meters line of site.

Wireless Security Recommendations

It is recommended that the IRMA System only be connected to networks employing the WPA or WPA2 protocol.

NCC e-labelling Access

The NCC e‐labelling is located on the About IRMA screen of the IRMA Tablet. See Section 4.3 IRMA Functions.

Indoor Use Only

If this device is to be operated in the 5.15 - 5.25 GHz frequency range, it is restricted to indoor environments only.
G.13 IRMA System Wireless Coexistence
The minimum distance from a Bluetooth transmitter is shown in Table G.6.
Transmitter Power Distance from IRMA Tablet
100 mW 230 mm (9.06 inches)
10 mW 70 mm (2.76 inches)
G.14 Accuracy
Table D.1 in section D.1 of the IRMA System User Manual is replaced by the following in Table G.7:
Analyte
pH
pCO mmHg
2
pO mmHg
2
Sodium (Na + ) mmol/L
Potassium (K + ) mmol/L
Ionized Calcium (iCa) mmol/L
Hematocrit (Hct) %
Document Description
American National Standard for Evaluation of Wireless Coexistence as per AAMI TIR69:2017, Risk
management of radio-frequency wireless coexistence for medical devices and systems.
Tested
Number of
(Reportable)
Samples
Range
7.073 - 7.660
40
(6.500 - 8.000)
14.5 - 111.1
40
(4.0 - 200.0)
39.0 - 210.1
40
(10.0 - 700.0)
90.6 - 149.2
40
(80.0 - 200.0)
1.17 - 13.57
40
(1.00 - 15.00)
1.23 - 4.18
40
(0.20 - 4.50)
10.6 - 68.7
40
(10.0 - 80.0)
Distance from IRMA Base
100 mm (3.94 inches)
30 mm (1.18 inches)
Passing - Bablock Regression
Slope Intercept
1.046 -0.335
1.038 -1.999
1.003 -0.129
0.988 0.950
0.988 0.033
1.022 -0.040
1.048 -2.490
G.9
9 Apéndices
Table G.6
Table G.7
Bland-Altman Distribution Results
S
Mean Bias
y.x
Std Error of Mean
0.005 0.006
0.380 -0.023
0.735 0.193
0.315 -0.145
0.036 -0.054
0.016 0.018
0.303 0.743